Z-0053-2012

Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip...

Name: Z-0053-2012 Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-09-13
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-09-13 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector on 2011-09-13. The reason FDA records is "Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0053-2012
Status: Terminated
Initiated: 2011-09-13
Posted: 2011-10-17
Terminated: 2012-12-10
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector
Product code: DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.
Quantity in commerce: 9770
Distribution: Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.
Product codes and lots: Catalog number 4300 and CV-4300

Product code DTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)